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Impurity reference standards

Lopinavir impurity standards

Zemixal lists 12 reference materials related to Lopinavir, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 5 pharmacopoeial impurities.

12reference materials
5pharmacopoeial

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Pharmacopoeial5EP, USP, BP or JP named impurities

Counts are based on product names. One compound can fall into more than one type.

All Lopinavir reference materials

1–12 of 12 standards
Questions

Lopinavir impurities, answered

How many Lopinavir impurity standards does Zemixal list?
The catalogue currently lists 12 compounds for Lopinavir, including 5 pharmacopoeial impurities. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Lopinavir impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Lopinavir impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.

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